Table 1: Carbonated soft drink product description.

Product Description:

Carbonated Soft Drink-Cold Processing

Product Name(s) or SKU:

Pepsi, 7up, Mirinda, Mirinda Green Cream Mountain Dew, Sting Berry Blast. Pepsi Diet, 7up Free, 7up Diet,7up mint

RGB (Returnable Glass Bottle): 250 ml & 240 ml CAN: 250ml, 300ml

PET:300ml, 345ml, 500ml, 1000ml, 1500ml, 1750ml, 2250ml.

Intrinsic Product Attributes: (Food Safety Characteristics) - Including Ingredients

Treated Water, CO2, Sugar-Sucrose Syrup, Sodium Benzoate, Citric Acid, Caffeine, PI flavors (Pepsi, 7up, Mirinda, Mountain Dew, Sting Berry Blast, Pepsi Diet, 7up Free, 7up Diet,7up Mint, Mirinda Green Cream) (Acidic)

Customer/Consumer Use:

Ready to use

No cooking/processing required

Target Market:

Teenagers and Adults

Vulnerable Consumer:

Diabetic Patients (except 7up free, Pepsi Free and Diet Products like 7up Diet and Pepsi Diet), Carrying mothers (Sting, Dew, Pepsi Only)

Special Distribution & Storage Control:

Storage at Ambient temperature, under shed, protect from direct sunlight.

Shelf Life: (If Applicable)

PET = 6 months

Sugar Free (7up & Pepsi) = 6 months Glass = 9 months

Can = 6 months

Can Diet = 6 months Can Sting BB = 1 year

Label Instructions:

Product Name, Brand Name, Name and Address of the Manufacturer, Net Content, Nutritional facts, Caloric Contents of Products, Ingredients, Serving instructions, Storage Instructions, Production Date and Expiry Date

Method of Distribution:

Delivery in Clean Covered vehicles having cover on it.

Table 2: Characteristics relevant to food safety.

Characteristics Relevant to Food Safety

Carbonated Soft Drink

Physio

7up: As is brix:10.65± 0.2, CO2 PET:3.25-4.24, CO2 RGB:3.45-3.94, TA:22.36-24.70

Pepsi: As is brix:10.45± 0.2, CO2 PET:3.15-4.42, CO2 RGB;3.35-3.84, TA:10.90

Mountain Dew: As is brix:11.85± 0.2, CO2 PET:2.75-3.84, CO2 RGB;2.95-3.45, TA:18.91-21.02

Mirinda Orange: As is brix:12.95± 0.2, CO2 PET:1.35-2.44, CO2 RGB:1.5-2.05, TA:26.53-29.12

Mirinda Green Cream: As is brix:10.50± 0.2, CO2 PET:2.80-3.10, TA:6.94-7.36

7up Mint: As is brix:11.05± 0.2, CO2 PET:2.80-3.20, CO2 CAN:2.40-2.80 TA:38.18-40.54

Sting Berry Blast: As is brix:15.15± 0.2, CO2 PET:2.80-3.38, CO2 RGB:2.35-2.85, TA:50.35-53.04

7up Free :As is brix:0, CO2 PET:3.25-4.24, CO2 RGB;3.45-3.94, TA:25.50

Pepsi Diet :As is brix:0, CO2 PET:3.15-4.42, CO2 RGB;3.35-3.84, TA:13

Chemical

N/A

Microbiological

Yeast ≤ 15/100mL, Mold ≤ 15/100mL,

Aciduric Bacteria < 30/100mL TPC < 100 cfu/ml

Coliform < 10 cfu/ml

Table 3: Intended use of carbonated soft drinks.

Queries related to product use

Carbonated Soft Drink

Will the product be cooked or heated by the consumer?

No

Will the product need specific storage until consumed?

Yes, Stored at ambient temperature at covered places away from direct sunlight.

Is the product likely to be mishandled by the consumer?

Yes, Poor handling can result in cross contamination.

Are there any vulnerable groups in the target market?

Yes, sugar and caffeine based CSD, kids carrying mothers and diabetic patients

Are there any specific allergens?

No

Are there any allergen claims made?

No

Table 4: Severity determination level of hazards and effect of hazards.

Severity Determination

Severity If control fails:

Effect of severity if hazard occurs

Multiplier

Little Damage

Consumer disappointed.

1

Damage

Illness at home. Medical treatment not necessary.

2

Serious Damage

Minor medical treatment may be necessary (for example a broken tooth).

3

Very Serious Damage

Illness at home with medical treatment necessary.

4

Disaster serious illnes

Hospitilization Require

5

Catastrophic

Death

6

Table 5: Probability of risk determination level of hazard.

Risk/Likelihood Determination

Probability of hazard occurring under current conditions

Likelihood That Hazard Could Occur

Multiplier

Almost Impossible/Improbable

No history of it occurring in facility or across the food and beverage industry

1

Un-Likely/Remote

Very occasional, has been known to occur in the facility or in a similar industry

2

Small Risk/Possible

Could be an isolated event that results after manual operations – would expect to happen occasionally in a year

3

Likely/Probable

Product or operational factors that can be expected to be present – could happen a number of times in the year

4

Certain/Frequent

Product or operational factors that are always present that the process is expected to control – occurs repeatedly

5

Table 5: Probability of risk determination level of hazard.

Risk/Likelihood Determination

Probability of hazard occurring under current conditions

Likelihood That Hazard Could Occur

Multiplier

Almost Impossible/Improbable

No history of it occurring in facility or across the food and beverage industry

1

Un-Likely/Remote

Very occasional, has been known to occur in the facility or in a similar industry

2

Small Risk/Possible

Could be an isolated event that results after manual operations – would expect to happen occasionally in a year

3

Likely/Probable

Product or operational factors that can be expected to be present – could happen a number of times in the year

4

Certain/Frequent

Product or operational factors that are always present that the process is expected to control – occurs repeatedly

5

Table 7: Hazard Identification and analysis for CSDs.

Operations

Type of Hazard

Cause of Haz- ard

Significance of Hazard

Justification for

Decision

Control Measure

Sever- ity of Haz- ard

Likeli- hood of Hazard Occur- ring

Risk

Signifi- cant Haz- ard (Yes or No)

1.1 Source Water

Physical: Sand, Mud etc.

Occurrence in ground water

2

3

6

No

Water Treatment Process In Place

Water Treatment System as

Per PEPSICO guidelines and annual

testing through external Lab

Chemical: Heavy Metals

Carried with ground water

2

2

4

No

Water Treatment Process In Place

Water Treatment System as

Per PEPSICO guidelines and annual

testing through external Lab

Biological: Presence of Total Coliform, E.coli

Carried with ground water

4

2

8

No

Water Treatment Process In Place

Water Treatment System as

Per PEPSICO guidelines and annual

testing through external Lab

1.2 Sugar

Biological: Presence of TC, Mold, yeast

From supplier process

6

1

6

No

Controlled by supplier. Certificate of analysis on delivery and RM tested.

Supplier Quality Assurance Program.

Physical: Presence of FB

e.g. metal

filings.

From Supplier drier process.

3

1

3

No

Controlled by supplier. CoA on delivery and RM tested.

RM specifications in

place.

Filtration step later in process will address hazard.

Supplier Quality Assurance Program, Filtration.

Chemical: Heavy Metals

From supplier process

3

1

3

No

Controlled by supplier. Certificate of analysis on delivery.

Supplier Quality Assurance Program.

1.3

Concentrate

Biological: Presence of TC, Mold, yeast

From supplier process.

6

1

6

No

Controlled by supplier (Pepsico). RM specifications in place. pH too low to sustain pathogen growth.

Pepsico Quality Assurance Program.

Physical: Presence of FB

e.g. metal

filings.

From supplier process.

3

1

3

No

Controlled by supplier (Pepsico). RM specifications in place.

Filtration step later in process will address

hazard.

Pepsico Quality Assurance Program.

Chemical: Presence of industrial grade components

e.g. citric acid.

From supplier process.

4

1

4

No

Controlled by supplier (Pepsico). All components are food grade. RM specifications

in place.

Pepsico Quality Assurance Program.

1.4 Preforms

Biological: Presence of mold, TC

Unhygienic handling in supplier proc- ess.

1

1

1

No

Controlled by supplier. Fully automated system with hygiene standards in place.

RM specifications in

place.

Approved supplier.

Supplier Quality Assurance Program.

Physical: Presence of FB

e.g. metal

filings.

From supplier process.

1

1

1

No

Controlled by supplier. RM specifications in place.

Approved supplier.

Supplier Quality Assurance Program.

Chemical: Presence of toxic chemicals.

From supplier process.

1

1

1

No

Food grade certificate. RM specification in place.

Approved supplier.

Supplier Quality Assurance Program.

1.5 Caps

Biological: Presence of mold,

TC

Unhygienic handling in supplier proc- ess.

6

1

6

No

Controlled by supplier. Fully automated system. RM specifications in place.

Supplier Quality Assurance Program.

Physical: Presence of FB

e.g. hair.

From supplier process.

1

1

1

No

Controlled by supplier. Fully automated system with hygiene standards in place.

RM specifications in

place.

Supplier Quality Assurance Program.

Chemical: Presence of toxic chemicals.

From supplier process.

1

1

1

No

Food grade certificate. RM specification in place.

Supplier Quality Assurance Program.

1.6 Labels

Biological: NILL

-

-

-

No

Secondary Packaging.

No hazard Exist

Physical: NILL

-

-

-

No

Secondary Packaging.

No hazard Exist

Chemical: NILL

-

-

-

No

Secondary Packaging.

No hazard Exist

1.7 Empty Cans and Ends

Biological: NILL

-

-

-

No

No hazard Exist

Supplier Quality Assurance Program

Physical: Dust

Due To dam- age secondary packaging damage

1

1

1

No

Not likely to occur

Chemical: NILL

-

-

-

No

No hazard Exist

1.8 Shrink Wrap Film

Biological: NILL

-

-

-

No

No hazard Exist

Physical: NILL

-

-

-

No

No hazard Exist

Chemical: NILL

-

-

-

No

No hazard Exist

1.9 CO2

Biological: NILL

-

-

-

No

No hazard Exist

Physical: NILL

-

-

-

No

No hazard Exist

Chemical: Presence of toxic impurities.

From supplier process.

3

1

3

No

Approved supplier used, food grade CO2, purity tested on delivery, ingredient

specification available,

CoA on delivery.

Supplier Quality Assurance Program.

2.1 CO2 purity

Biological: NILL

-

-

-

No

No hazard Exist

Physical: NILL

-

-

-

No

No hazard Exist

Chemicals: Presence of adulterating chemicals.

From supplier process.

4

1

4

No

Controlled by supplier. CoA on delivery and CO2 tested

for purity. RM

specifications in place.

Supplier Quality Assurance Program.

2.2

CO2 unloading

Biological: NILL

-

-

-

No

No hazard during unloading

Physical: Foreign Matter

During con- necting pipe- line with tank line

1

1

1

No

Not likely to be occurred

CO2 Filtration

Chemical: NILL

-

-

-

No

No

3.0 Storage

Biological: Growth of vegetative pathogens.

Cross contam- ination from damaged packaging.

2

1

6

No

Good warehouse practices in place. Staff well trained and GMP being followed.

GMP, training.

Physical: introduction of FB.

From en- vironment through dam- aged packag- ing.

3

1

3

No

Good warehouse practices in place. Staff well trained and

GMP and cleaning

schedule being followed.

GMP, GHP, training.

Chemicals: Introduction of excrements from pests.

Cross contam- ination from pests through damaged packaging.

4

1

4

No

Integrated pest management system being followed. Good warehouse practices in place. Staff well trained and

GMP and cleaning

schedule being followed.

Pest control, GMP, GHP, training.

4. Cl2 Dosing

Physical: Foreign Particle

From Incom- ing Bag

2

2

4

No

Manage through PRP

Incoming inspection program

Chemical: Cl2

Chemical Con- tamination due to over dosing of Cl2.Impurities in Cl2

3

2

6

No

Manage through PRP

Carbon Purifier

Biological: NILL

-

-

-

No

No biological hazard exist

4.1 - Raw

Water Reservoir

Physical: NILL

Present in po- table water

1

1

1

No

Not likely to occur

Filtration through Sand and micron

filtration

Chemical: Cl2

Overdosing of Cl2

3

2

6

No

Manage through PRP

Carbon Purifier in next program

Biological: E.

coli Coliform

Low dosage of Cl2

3

2

6

No

Manage through PRP

UV

4. 2 Brine Solution

Physical: Foreign Matter

Incoming material and handling

1

2

2

No

Not significant hazard

Incoming material inspection

Chemical:

-

-

-

No

No significant hazard

occurred

Biological: Total Coliform

Micro Con- tamination during annual maintenance from air, area & personal handling.

2

2

4

No

Manage through PRP

Micro analysis of water

4.3 Softener

Physical: Foreign Matter

Probably present in treated water

1

2

2

No

No likelihoods

Back washing of softener and

changing at defined frequency

Chemical: NILL

-

-

-

No

No biological hazard exists

Biological: Total Coliform

Micro Con- tamination during annual maintenance from air,

2

2

4

No

Manage through PRP

Micro analysis of water

4.4 Chemical Dosing

Physical: Foreign Particles

From Incom- ing Bag

2

2

4

No

Manage through PRP

Testing at defined frequency

Chemical: Ferrous and Lime

Contamina- tion due to over dosing of chemical

2

2

4

No

Manage through PRP

Testing at defined frequency

Biological

-

-

-

No

No biological hazard exists

4.5 Buffer Tank

Physical:

0

0

0

No

No significant hazard

occurred

Chemical: High Chlorine concentration

Overdosing

3

2

6

No

Manage through PRP

?Chlorine concentration is maintaining through water analysis as per defined frequency (>1

ppm)

?Removal of total chlorine through

Carbon Filter

Biological:

E.coli

Contamina- tion improper dosing

3

3

9

No

Manage through PRP

?Chlorination (6-8ppm) is

maintained in buffer tank.

?Microbiological monitoring at plant's laboratory. ?Hygienic conditions of area and personnel

are being followed.

4.6 Carbon

Purifier

Physical: Foreign Particles, carbon particles

2

2

4

No

Manage through PRP

Follow Backwash frequency, Use Potable water

Chemical: Cl2

Improper Back washing

4

3

12

As there is no other step for removal of chlorine and Likelihood is lower

OPRP-1

Biological: Total Coliform

Micro Con- tamination during annual maintenance from air, area & personal handling.

2

2

4

No

Manage through PRP

Follow Sanitation frequency, Use Potable

Water

4.7 Polisher

Physical: Foreign Matter

Probably present in treated water or person

4

3

12

There is no filter this is a last point but likelihood is lower

OPRP-2

Chemical: NILL Biological: Total Coliform

Micro Con- tamination during annual maintenance from air, area & personal handling.

- 2

- 2

- 4

No No

No biological hazard exist

Manage through PRP

Hygienic conditions of area and personnel are being followed. Disinfection of filters before installation.

4.8 UV

Physical: NILL

-

-

-

No

No biological hazard exist

Chemical: NILL

-

-

-

No

No biological hazard exist

Biological: Total bacteria, coliform

Present in portable water

4

3

12

High acidic product. Likelihood is lower

Lamp replacement at defined frequency and micro testing at defined frequency (OPRP-3)

5.0 Sugar Dumping

Physical: Foreign matter, threads, stones

Sugar Bags

2

2

4

No

Manage through PRP

Filtration of syrup in next steps

Biological: Contamination of Sugar from personals

Unhygienic condition

2

2

4

No

Manage through PRP

Area GMP and Personnel Hygiene

Chemical: NILL

No

Not likely to be occurred

Chemical control program

5.1 Steam

Physical: NILL

-

-

-

No

Not likely to be occurred

No direct contact

Chemical: Boiler chemical

Non-Food grade chemical

2

2

4

No

Manage through PRP

No Chemicals Used

Biological: Microorganism

From water due to inappropriate Filter

1

2

2

No

Manage through PRP

Micro analysis of soft water

5.2 Filtration

Physical: Suspended particle

Cross Contamination

3

2

6

No

Manage through PRP

Visual inspection of simple syrup after each filtration.

Biological: yeast, mold total count

Filter Chocking

4

2

8

No

Not likely to be occurred

Cleaning and Sanitation program

Chemical: NILL

-

-

-

No

Not likely to be occurred

Close circuit, Cleaning and Sanitation program

5.3 Cooling through Heat Exchanger

Physical: NILL

-

-

-

No

Not likely to be occurred

Chemical: Coolant Contamination

Leakage

3

1

3

No

No direct contact

Simple syrup inspection, maintenance program

Biological: NILL

-

-

-

No

Not likely to be occurred

Cleaning and Sanitation program

5.4

Concentrate Components

Physical: Foreign Particles,

paper, tape and polythene

pieces

Present in Cartons

2

2

4

No

Manage through PRP

Filtration of final syrup

Biological: NILL

-

-

-

No

Not likely to be occurred

Chemical: NILL

-

-

-

No

Not likely to be occurred

5.5 Mixing Tank

Physical: Foreign Particles,

paper, tape and polythene

pieces

During Mixing of Ingredients

2

2

4

No

Manage through PRP

Filtration of final syrup

Biological: Yeast, Mold & Total Coliform

Air borne micro contamination & non-appropriate cleaning and sanitation of mixing tank.

2

2

4

No

Manage through PRP

*Cleaning and sanitation of mixing tank.

(PRP)

* Personal Hygiene and area GMP (PRP)

Chemical: NILL

-

-

-

No

Not likely to be occurred

Cleaning and Sanitation program

6.1 CO2 Filtration

Physical: NILL

-

-

-

No

Not likely to be occurred

Chemical: Impurities

From Supplier

3

2

6

No

CO2 From Approved Suppler

Annual Lab Analysis

From Approved Supplier TOA for each delivery

Biological: NILL

-

-

-

No

Not likely to be occurred

Close circuit

6.2 De-aeration

Physical: NILL

-

-

-

No

Not likely to be occurred

Close circuit

Chemical: NILL

-

-

-

No

Not likely to be occurred

Close circuit

Biological: NILL

-

-

-

No

Not likely to be occurred

Close circuit

6.3 Final Syrup Mesh Filtration

Physical: Foreign Particles,

paper, tape and polythene pieces,

Pump Rubber

Escape of item due to inappropriate filtration

4

4

16

This is last step for

filtration

Daily 100 mesh strainer inspection

Chemical: NILL

-

-

-

No

Not likely to be occurred

Biological: Micro organism Yeast & Mold

Micro contamination during maintenance of pump from personal contact and from area.

2

2

4

No

Manage Through PRP

Area and Personnel Hygiene

6.4 Syrup receiving & Proportioning

Physical: Foreign Particles, paper, tape and polythene pieces, Pump Rubber Seals

From Syrup and water

2

2

4

No

Filtration

100 mesh strainer at syrup lines

and 5 micron filter on air

Chemical: Residue

Contamination from residue from Changeover or sanitation

2

2

4

No

Verification after

each CIP

CIP SOP and Changeover Matrix

Biological: NILL

Yeast, Mold

2

2

4

No

Not likely to occur

CIP SOP and Changeover Matrix

6.5 Carbonation

Physical: Foreign matter

From supply lines and tanks

2

2

4

No

Filter are in place

Purging of line, Filter maintenance

Chemical: Impurities

From Supplier

2

2

4

No

Incoming COA/COC TOA on each delivery

Annual lab Analysis of CO2

Biological: NILL

-

-

-

No

Not likely to be occurred

6.6 Mixer Product Tank

Physical: NILL

-

-

-

No

Not likely to be occurred

Chemical: NILL

-

-

-

No

Not likely to be occurred

Biological: Yeast, Mold

Ineffective sanitation

2

1

2

No

Not likely to be occurred

Sanitation and Micro Sampling

7.1 Washer

Physical: Cemented Bottles, Chipped bottles, Cracked Bottles & Bottles

containing foreign matters (with sharp edges, stones, glass pieces), Other

brand bottles

Contaminated Container and improper pre wash inspection

2

2

4

No

Control Measures in place and effective

Sorting of all such bottles by trained visual inspectors at first light & final light.

Washing through washer

Chemical: chemical residue

Carryover along contamination

2

2

4

No

Control Measures in place and effective

?Visual inspection of jets for

alignment.

?Maintain required rinsing

conditions including:

•Pressure of jets >1.5 bar

•Accurate alignment of jets.

•Maintained pH 7-8

•Concentration of caustic >2.0 %

•Contact Time: 7 minutes

Biological: Survival of E. coli, Salmonella & Salmonella & another mold.

From storage and handling

3

3

9

No

Control Measures in place and effective

?Bottles are thoroughly washed & sanitized to ensure elimination of pathogens. Following conditions are maintained for cleaning sanitation of containers

?Visual inspection of jets for

alignment

•Temperature of water: 60-70 ?C

•Concentration of caustic solution

>2.0 %

•Contact Time of caustic with

container : 7 minutes

•Additives

•Microbiological analysis as per defined

frequency

•Mold test of washed container after

washing

7.2 Hopper Filling

Chemical: NILL

No food safety hazards were identified.

-

-

-

No

No Significant

Hazard Occur

Biological: NILL

Pest activity while feeding the hopper cover is open

3

1

3

No

GMP

Pest control program implementation

Physical: NILL

Dust (uncleaned surface) + Packing Remains

1

1

1

No

GMP

GMP and regular inspection

7.3 Preform Lift conveyor

Chemical: NILL

-

-

-

No

No Significant

Hazard Occur

Biological: Mold, Yeast

Pest activity while the cover is open

3

1

3

No

GMP

Pest control program implementation

Physical: Foreign Matters

Dust (uncleaned surface)

1

1

1

No

Control Measures in place and effective

GMP and regular inspection

7.4 Preform Neck Camera Inspection

Chemical NILL

-

-

-

No

No Significant

Hazard Occur

Biological: Yeast, Mold

Pest activity while the cover is open

2

1

2

No

GMP

Pest control program implementation

Physical: Foreign Matter

Dust (uncleaned surface)

1

1

1

No

GMP

GMP and cleaning by ionized air

7.5 Compressed Air

Physical: NILL

2

0

0

No

Control Measures in place and effective

Filters in Place

Chemical: NILL

Oil Used for Lubrication

2

0

0

No

Control Measures in place and effective

Oil free compressors are in use

Microbiological: Yeast and Mold

Environment

2

1

2

No

Control Measures in place and effective

Environment and Empty PET

Microbiology Testing Done

7.6 Blowing Molds

Chemical: Lubricants

Lubrication

1

1

1

No

GMP and regular cleaning

Food Grade greases are being used

Biological: Mold, Yeast

Pest activity while the cover is open

1

1

1

No

Control Measures in place and effective

Pest control program implementation

Physical: Foreign Matter

Dust (uncleaned surface)

1

1

1

No

Control Measures in place and effective

GMP and cleaning

7.7 Bottle Guiding Star

Chemical: Lubricants

Lubrication

1

1

1

No

Control Measures in place and effective

Food Grade greases are being used and below bottle neck

Biological: Mold, Yeast

Pest activity while the cover is open

1

1

1

No

Control Measures in place and effective

Pest control program implementation

Physical: Foreign Matter

Dust (uncleaned surface)/ Rust on the grippers

1

1

1

No

Control Measures in place and effective

GMP and cleaning

8.1 Air Conveyors

Chemical NILL

-

-

-

No

Not likely to be occurred

Biological: Yeast, Mold

Pest activity while the cover is open

1

1

1

No

GMP

Pest control program implementation

Physical: Foreign Matter

Dust (uncleaned surface)/ Rust on the guiding strip

2

1

2

No

GMP and design

GMP and cleaning

8.2 Base Cooling

Physical: NILL

No

Not likely to be occurred

Chemical: NILL

-

-

-

No

Not likely to be occurred

Biological: NILL

-

-

-

No

Not likely to be occurred

8.3 Labeling

Physical: NILL

-

-

-

No

Not likely to be occurred

Chemical: NILL

-

-

-

No

Not likely to be occurred

Biological: NILL

No

Not likely to be occurred

8.4 Rinse

Physical: Dust particles

Poor rinsing

1

2

2

No

Control Measures are effective

Rinse Pressure monitoring Rinse alignment monitoring

Chemical: Residual Water

1

2

2

No

Control Measures are effective

Residual Volume monitoring

Biological NILL

-

-

-

No

Not likely to be occurred

8.5 Crown/closure Debagging and transfer to hopper

Physical: NILL

-

-

-

No

Not likely to be occurred

Chemical: NILL

-

-

-

No

Not likely to be occurred

Biological: NILL

-

-

-

No

Not likely to be occurred

8.6 Filling

Physical: Presence of sharp-edged glass fragments,

Carrying of foreign particles from empty bottle

inspection

Its due to bottles bursting, Second occurs due to untrained bottle inspectors.

3

3

9

No

Control Measures are effective

*Bottle failure Procedure

*Training of bottle inspectors.

Chemical: NILL

No significant

hazard occurs

-

-

-

No

Not likely to be occurred

Microbiological: Microbiological contamination (mold, yeast)

Its due to Non- appropriate cleaning of containers

Dirty filling equipment From air-borne

micro-organisms. Personal contacts Dirty bottles due to poor inspection of bottles by untrained

bottle inspectors.

3

2

6

No

Control Measures are effective

Monitoring Washer parameters. Cleaning & Sanitation of process equipment’s (CIP).

Area GMP and Personal Hygiene* Training of bottle inspectors.

8.7 Capping

Physical: Cap shoot particles & tap and paper pieces

Its comes from cap cartons, improper cleaning

3

2

6

No

Control Measures are effective

Cleaning & Maintenance of equipment as per schedule.

Manual Cleaning of cartons before opening.

*Training of filler operators.

Chemical

-

-

-

No

Not likely to be occurred

Microbiological: Air borne microorganisms & Mold

Its comes from personal and second due to improper cleaning

2

2

4

No

Control Measures are effective

Area and machine GMP and personal Hygiene

8.8 Date Coding

Physical: NILL

-

-

-

No

Not likely to be occurred

Chemical: NILL

-

-

-

No

Not likely to be occurred

Biological: NILL

-

-

-

No

Not likely to be occurred

8.9 Bottle

Inspection

Physical: cracked and foreign matter

bottle and machine contact

2

2

4

No

Control Measures are effective

Bottles Inspectors training

Chemical NILL

-

-

-

No

Not likely to be occurred

Biological: NILL

-

-

-

No

Not likely to be occurred

8.10 Warmer

Physical: Bottles crack

High temperature of water

2

2

4

No

Control Measures are effective

Monitoring of Temperature

Chemical: NILL

-

-

-

No

Not likely to be occurred

Microbiological:

Mold, E.Coli

-

-

-

No

Not likely to be occurred

treated water used and micro sampling

8.11 Washed Containers Visual Inspections

Physical: Non- removed foreign matters, Glass particles from breakage of bottles due to thermal

shock, damaged pockets, other

brand bottles

Improper cleaning and not removal by EBI and Prewash inspectors

2

2

4

No

Control Measures are effective

Inspection of washed containers at light by trained & permanent visual inspectors.

Chemical: oil, greasy, paint

From washer

2

2

4

No

Control Measures are effective

Inspection by trained visual inspectors

Biological: air bone

contamination

From Handling and improper washing

2

2

4

No

Control Measures are effective

Good cleaning and hygienic practices. Monitoring of air quality at defined frequency

9.1 Case Packing

Physical: NILL

-

-

-

No

Not likely to be occur

Chemical: Residual oil

From Air

-

-

-

No

Not likely to be occur

Biological: Mold

From sugar due to leakage of any previous product

1

1

1

No

Control Measures in place

Leak can sort out

9.2 Shrink Wrap

Physical NILL

-

-

-

No

Not likely to be occur

Chemical NILL

-

-

-

No

Not likely to be occur

Biological NILL

-

-

-

No

Not likely to be occur

9.3 Palatizing

Physical NILL

-

-

-

No

Not likely to be occur

Chemical NILL

-

-

-

No

Not likely to be occur

Biological NILL

-

-

-

No

Not likely to be occur

9.6 Storage

Biological: Micro Growth TC, Yeast, Mold

Cross contamination from damaged packaging.

6

1

6

No

Effective Control

Measures in place

Good warehouse practices in place. Staff well trained and GMP being followed MP, training.

Physical: Introduction of FB.

From environment through damaged packaging.

3

1

3

No

Effective Control

Measures in place

Good warehouse practices in place. Staff well trained and GMP and cleaning schedule being followed MP, GHP, training.

Chemicals: Introduction of excrements from pests.

Cross contamination from pests through damaged packaging.

4

1

4

No

Effective Control

Measures in place

Integrated pest management system being followed. Good

warehouse practices in place. Staff well trained and GMP and cleaning schedule being followed

MP, GHP, training.

8.12 Seamer

Physical: Dust can enter

-

-

-

No

Not likely to be occurred

Chemical NILL

-

-

-

No

Not likely to be occurred

Biological:

Air bone contamination

Due to improper sealing

2

2

4

No

Control Measures are effective

Seamer Inspection

Table 8: OPRP plan for CSDs.

OPRP Plan for CSDs Lines

OPRP #

& De-

scrip- tion

Food Safety Hazard to be control- led

Control Measure

Critical Limit

Monitoring Procedures

Correction

Correc- tive Ac- tions

Re- sponsi- bility & Author- ity (Who?)

Records Of Moni- toring and Loca- tion

What

How

Fre- quency

Who

Activity

Method to be used

How of- ten?

Responsi- ble

for moni-

toring?

Activity (What?)

Activity (What)

Acti- vated Car- bon Tank

Chemi- cal: High Residual Chlorine

Chlorine NILL after activated Carbon Tank

NILL

Chlo- rine moni- toring after A.C

Colorim- eter

At star- tup and every four hours

Water Treatment operator

Hold the pro- duction from last good check to current check random sam- ples and decide accordingly

Carry out root cause analysis and take corrective actions

Process Engi- neer

Water treatment quality report

5 Mi-

cron Filter

Physical: Sand/ Acti- vated Carbon particles

Physical: Sand & Silt Parti- cles

Pressure Drop < 5 PSI

Pres- sure Drop Calcula- tion

Visual monitor- ing

Daily

Water Treatment operator

Hold the pro- duction from last good check to current check random sam- ples and decide accordingly

Carry out root cause analysis and take corrective actions

Process Engi- neer

Filter change record Available in Water Treatment

UV

Biologi- cal: Colif- orm

UV moni- toring and micro analysis

Intensity >70 % Operating Hours < 8000 hours

Total bacteria 50/100mL, col- iform bacteria (cfu)

0/100mL

Micro- bial Count of treated water Mainte- nance Log of UV

Visual monitor- ing/ Micro results

UV pa- rameters monitor- ing once in 8hour shift

and weekly micro analysis

Microbiol- ogist Water Treatment Operator

Hold the pro- duction from last good check to current check random sam- ples and decide accordingly

Carry out root cause analysis and take corrective actions

Process Engi- neer

Micro- biology reports, 5 Step

CIP re- ports, UV mainte- nance Log Available in Water

Treatment

Table 9: CCP determination for CSDs.

CCP Determination for Carbonated Soft Drink

Process Step

Hazard Type

Control Measure

Is the haz- ard com- pletely controlled by a pre- requisite program?

Decision Tree Answers

Justification of Decision

Q-1

Do pre- ventable control measures exist?

Q-2

Is the step specifically designed to eliminate or reduce the likely occurrence of hazard to an ac- ceptable level?

Q-3

Could con- tamination with identi- fied

hazard oc- cur in excess of accept- able level or could these increase to unacceptable

levels?

Q-4

Will a subse- quent step eliminate identified hazard

or reduce likely occurrence to accept- able level?

CCP

(Yes/No)

, CCP#

Final Syrup Strainer

Physical: Foreign Object s

Yes Filtration with the filter of mesh size 100

NO

Yes

Yes

Yes

No

YES CCP1

The inline 100 mesh filter positioned as the last filtration step at the closest point prior to filling specifically designed to control the

identified foreign object hazards. As Syrup Room is the last manual Handling

Operation

Table 10: CCP control chart for CSDs.

Proc- ess Step / CCP#

CCP #

Type of Hazard

Control Meas- ure

Critical Limits

Monitoring Procedures

Correc- tion

Correc- tive Ac- tions

Responsibil- ity & Au- thority (Who?)

Records Of Monitor- ing and Location

What

How

Frequen- cy

Who

Activity (What?)

Activity (What?)

Activity

Method to be used

How of- ten?

Respon- sible for monitor- ing?

Final Syrup Strain- er

CCP # 1

Physi- cal: Pres- ence of foreign matter

Flltra- tion Through inline 100

mesh

filter

Absent, Filter intact and free of foreign matter

Mesh filter (located prior to filling).

Visual in- spection of the filter/ screen for integrity, assembled correctly and of the correct size for the prod- uct

Daily

Syrup Room Op- erator

1.If filter/ screen is not

present, intact or the cor- rect

size during verifica- tion, check on hold, stop

the proc- ess, place the ma- chine "out of order". 2.Notify designated quality employee.

3.Conduct risk as- sessment to evaluate the likeli- hood of

the hazard. 4.Replace damaged filter with a function-

al filter.

Carry out root cause analysis as correc- tive and preven- tive action program

Process Engineer/ Syrup Room Operator/ FSTL

Strainer Inspection Record Available in

Syrup Room